Regulatory Affairs Manager

Newark, New Jersey

BioSpace, Inc.
Job Expired - Click here to search for similar jobs
Job Details

Job Description
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Live

What you will do

This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.

Responsibilities of the Promotions/Reviewer Manager is:

Attend required meetings in Amgens Material Approval & Compliance (MAC) process and review all preparatory materials
Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen
Update the Promotions group on new learnings and key takeaways from courses, congresses, and tradeshows
Assesses promotional programs against Regulatory requirements

Doctorate degree
OR
Masters degree and 3 years of Pharmaceutical or Biotech experience
OR
Bachelors degree and 5 years of Pharmaceutical or Biotech experience
OR
Associates degree and 10 years of Pharmaceutical or Biotech experience
OR
High school diploma / GED and 12 years of Pharmaceutical or Biotech experience

Preferred Qualifications:
BS Degree
Experience in reading, understanding, and applying promotional regulations to a constantly changing environment
Experience understanding and interpreting data/information and its practical application
Collaboration
Clinical knowledge/understanding
Analytical judgment
Negotiation/persuasion skills
Project management skills
Problem solving skills
Time management skills
Thrive
What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination

Objects in your future are closer than they appear. Join us.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Date Posted: 05 April 2025
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